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Ear-Zapping device may ease pain and opioid withdrawal

NCT ID NCT05555485

Symptom relief Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study tests a wearable device worn on the ear that stimulates nearby nerves to change brain signals. The goal is to see if it can reduce chronic pain and ease symptoms of opioid withdrawal. Adults aged 18 to 65 with chronic pain who are tapering off opioid medication will receive either real or fake stimulation over two days. Researchers will measure withdrawal symptoms, pain levels, and brain activity using MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous auricular neurostimulation device (Sparrow)
What this could lead to
If it works, this could offer a drug-free way to manage chronic pain and reduce opioid withdrawal symptoms.
What could go wrong
This is a small, early-stage study with only 60 participants. The device may not work better than a sham (fake) treatment, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females between 18 and 65 years of age * Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements * Presence of pain on more than half of the days in the last six months * Must have proof of prescribed medication by either showing a prescription bottle with the individual's name or the presence of a prescription on the Prescription Drug Monitoring Program (PDMP) * Willingness to taper opioid dose by at least 10% * Patient or provider requests opioid dose reduction or discontinuation. * Urine Drug Screen (UDS) must be positive for their prescribed opioid * Urine Drug Test must be negative for illicit drugs, benzodiazepines, and nonprescribed opioids * Must agree to use nicotine patches and/or gum instead of smoking or vaping in the UTMB facilities Exclusion Criteria: * Currently receiving treatment for cancer * Participant has a history of epileptic seizures * Participant has a history of neurological diseases or traumatic brain injury * Participant has abnormal ear anatomy or current ear infection present * Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators * Currently receiving a prescription benzodiazepine medication * Current prescription opioid dose \>50 MME/day * Current abuse of illicit drugs or alcohol (nicotine use is acceptable). * Surgery within the previous month * Report of suicide attempt or psychiatric hospitalization in the past 10 years. * Current suicidal ideation with specific plan or intent * Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study * Females who are pregnant or lactating * Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

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Conditions

The condition(s) this trial relates to.

agnosia chronic pain syndrome pain agnosia substance withdrawal syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Analgesia Opioid withdrawal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Texas Medical Branch

    RECRUITING

    Galveston, Texas, 77555, United States

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